Random-start Ovarian Stimulation in Egg-donors (ROSE)

Infertility Clinical Trial

— ROSE  

Official title:

Random-start Ovarian Stimulation in Egg-donors (ROSE) Trial: a Self-controlled Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02821819
• Other study ID #: IB012016
• Status: Terminated
• Phase: Phase 4
• Start date: January 10, 2017
• Est. completion date: January 12, 2018

Study information

• Verified date: July 2019
• Source: Instituto Bernabeu
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this prospective single-center study is to evaluate the laboratory outcome after random start ovarian stimulation in oocyte donors. The study will be performed in egg-donors but this type of treatment has the potential to be implemented in general infertility population.

Description:

The study group will start ovarian stimulation randomly in different moments throughout the menstrual cycle.

Randomization will take place on day 2-3 of the menstrual cycle, according to a list of random allocation of treatments and egg-donors will be assigned to random start ovarian stimulation: During follicular phase starting at day 5,7,9,11 or 13 of the menstrual cycle and during luteal phase starting at luteinizing hormone (LH) peak +3,+5,+7,+9 or +11.

Egg-donors will receive urinary follicle stimulating hormone (FSH) 150-225 IU/d in gonadotropin-releasing hormone (GnRH) antagonist protocol with cetrorelix acetate 0,25 mg/d starting five days after ovarian stimulation and a GnRH agonist trigger with triptorelin 0,2 mg to induce the final follicular maturation. Transvaginal ultrasound and serum analysis (estradiol, progesterone, LH and FSH) will be included for cycle monitoring.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: January 12, 2018
• Est. primary completion date: January 12, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• Premenopausal women

• 18-35 years old

• FSH levels < 10 IU/liter

• Antral follicle count (AFC) > 10

• Regular cycles

• Body Mass Index (BMI) < 28

• Signed informed consent

Exclusion Criteria:

• Polycystic ovary syndrome (PCOS) patients

• Allergy to gonadotrophins

• Concomitant participation in other trial

Related Conditions & MeSH terms

• Infertility

Intervention

Other:
• Random start ovarian stimulation
Egg-donors will start ovarian stimulation randomly at different moments throughout the menstrual cycle.

Drug:
• Gonadotrophins
Urinary FSH 150-225 IU/d
• GnRH antagonist
Cetrorelix acetate 0,25 mg/d starting five days after ovarian stimulation
• GnRH agonist
GnRH agonist triggering with triptorelin 0,2 mg for final follicular maturation.

Locations

Country	Name	City	State
Spain	Instituto Bernabeu	Alicante

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Bernabeu

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Mature Eggs	When collected, eggs retain numerous cells (granulosa or cumulus cells) surrounding the oocyte; this structure is termed as the cumulus oocyte complex (COC). Few hours later (2-4 hs), the oocyte is denuded from these cumulus cells, allowing for a clearer observation of the maturity status (presence or absence of a metaphase II) of the oocyte. The percentage of mature eggs represents the proportion resulting from dividing the total number of COCs collected by the number of metaphase II oocytes and multiplied by 100.	Up to 24 hours from the oocyte collection
Secondary	Fertilization Rate	Percentage of properly fertilized eggs after microinjection (ICSI) method	24 hours after day of oocyte collection

External Links

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